U.S. patent number 9,072,314 [Application Number 13/486,760] was granted by the patent office on 2015-07-07 for carotenoid-containing compositions and methods.
This patent grant is currently assigned to Mead Johnson Nutrition Company. The grantee listed for this patent is Zeina Jouni, Zeina Makhoul. Invention is credited to Zeina Jouni, Zeina Makhoul.
United States Patent |
9,072,314 |
Jouni , et al. |
July 7, 2015 |
Carotenoid-containing compositions and methods
Abstract
The present invention is directed to carotenoid compositions and
methods for inhibiting the growth of pathogenic bacteria or for
preventing or treating bacterial infections in subjects by
administration of an effective amount of astaxanthin and
beta-carotene.
Inventors: |
Jouni; Zeina (Battle Creek,
MI), Makhoul; Zeina (Tuscon, AZ) |
Applicant: |
Name |
City |
State |
Country |
Type |
Jouni; Zeina
Makhoul; Zeina |
Battle Creek
Tuscon |
MI
AZ |
US
US |
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Assignee: |
Mead Johnson Nutrition Company
(Glenview, IL)
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Family
ID: |
40588756 |
Appl.
No.: |
13/486,760 |
Filed: |
June 1, 2012 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20120238522 A1 |
Sep 20, 2012 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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12206838 |
Sep 9, 2008 |
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60986029 |
Nov 7, 2007 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A23L
5/44 (20160801); A61P 31/04 (20180101); A23L
33/26 (20160801); A61P 3/04 (20180101); A23L
33/10 (20160801); A23L 33/40 (20160801); A23V
2002/00 (20130101); A23V 2002/00 (20130101); A23V
2200/32 (20130101); A23V 2200/3202 (20130101); A23V
2250/211 (20130101); A23V 2002/00 (20130101); A23V
2200/332 (20130101); A23V 2200/3202 (20130101); A23V
2250/211 (20130101) |
Current International
Class: |
A61K
31/702 (20060101); A23L 1/29 (20060101); A61K
31/716 (20060101); A61P 31/04 (20060101); A23L
1/275 (20060101); A23L 1/30 (20060101); A23L
1/308 (20060101) |
References Cited
[Referenced By]
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Other References
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Nutrition, "Nutritional Factors and Helicobacter pylori Infection
in Colombian Children", 1997, vol. 25, No. 5, pp. 507-515. cited by
examiner .
Liu, B. H. et al., International Immunopharmacology, "Effect of
total secondary carotenoids extracts from Chlorococcum sp. on
Helicobacter pylori-infected BALB/c mice", 2003, vol. 3, pp.
979-986. cited by examiner .
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Nutrition, "Term Infants Fed Formula Supplemented with Selected
Blends of Prebiotics Grow Normally and Have Soft Stools Similar to
Those Reported for Breast-fed Infants", Mar. 2007, vol. 44, No. 3,
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examiner .
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Effects in Spontaneously Hypertensive Rats," Biol. Pharm. Bull.
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Strains in Japanese Children," J. Clin. Microbiology, Feb. 2002
vol. 40(2), p. 649-653. cited by applicant .
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Importance, and Advances in Testing," Gut 2004; 53:1374-1384. cited
by applicant .
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with astaxanthin in diabetic db/db mice," BioFactors 20 (2004)
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IOVS, Jun. 2003, vol. 44, No. 6, p. 2694-2701. cited by applicant
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Infection in Newborn Rhesus Macaques," J. Clinical Microbiology,
Dec. 2003, vol. 41 (12), p. 5511-5516. cited by applicant .
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Inhibit Helicobacter phylori Infection in BALB/cA Mice,"
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Primary Examiner: Jiang; Shaojia Anna
Assistant Examiner: Craigo; Bahar
Attorney, Agent or Firm: Patterson Intellectual Property
Law, P.C. Cartiglia; James R. Palmer; Tiffany N.
Parent Case Text
CROSS-REFERENCE TO RELATED PATENT APPLICATIONS
This application is a divisional application which claims priority
to commonly assigned U.S. patent application Ser. No. 12/206,838,
filed Sep. 9, 2008, which claims priority to U.S. Provisional
Application No. 60/986,029, filed Nov. 7, 2007, the disclosures of
which are incorporated herein by reference in their entirety.
Claims
What is claimed is:
1. A method for inhibiting the growth of H. pylori in an infant in
which H. pylori is present, comprising administering to the infant
a nutritional composition comprising a carbohydrate source, a lipid
source, a protein source, beta-carotene in an amount of from about
50 mcg/L to about 1150 mcg/L, astaxanthin in an amount of from
about 50 mcg/L to about 1150 mcg/L, polydextrose,
galactooligosaccharide, and Lactobacillus rhamnosus GG.
2. The method of claim 1, wherein the nutritional composition
comprises each of astaxanthin and beta-carotene in an amount within
the range of from about 75 mcg/L to about 230 mcg/L.
3. The method of claim 2, wherein the nutritional composition
comprises each of astaxanthin and beta-carotene in an amount within
the range of from about 100 mcg/L to about 200 mcg/L.
4. The method of claim 1, wherein the nutritional composition
comprises up to about 2000 mcg/L of the carotenoid blend.
5. The method of claim 1, wherein the nutritional composition
comprises galacto-oligosaccharide in an amount in the range of from
about 1.0 g/L to about 4.0 g/L.
6. The method of claim 1, wherein the nutritional composition
comprises polydextrose in an amount in the range of from about 1.0
g/L to about 4.0 g/L.
7. The method of claim 1 wherein the nutritional composition is an
infant formula.
8. The method of claim 1, wherein the nutritional composition
further comprises, in addition to the lipid source, arachidonic
acid and docosahexanoic acid having a weight ratio of from about
1:3 to about 9:1.
Description
BACKGROUND OF THE INVENTION
(1) Field of the Invention
The present invention relates generally to carotenoid-containing
compositions, methods for inhibiting the growth of pathogenic
bacteria, and methods for preventing or treating a bacterial
infection in a subject via the administration of carotenoids.
(2) Description of the Related Art
Approximately two-thirds of the world's population is infected with
Helicobacter pylori bacteria. Many people that are infected with
the bacteria never suffer any symptoms related to the infection. In
some cases, however, H. pylori infection can cause chronic active,
chronic persistent, or atrophic gastritis. Infection with H. pylori
also causes duodenal and gastric ulcers. In fact, H. pylori causes
more than 90% of duodenal ulcers and 80% of gastric ulcers. The
infection has additionally been associated with dyspepsia,
iron-deficient anemia, and gastric malignancy. Further,
approximately 15% of infected individuals will at some time develop
peptic ulcer disease or gastric adenocarcinoma, which is the second
most common cause of cancer deaths worldwide. Solnick, et al.,
Natural Acquisition of Helicobacter pylori Infection in Newborn
Rhesus Macaques, J. Clin. Microbio. 41(12): 5511-5516 (2003).
Helicobacter pylori, which was previously known as Campylobacter
pylori, is a gram-negative, spiral-shaped bacterium. It protects
itself from the harsh acidic environment of the stomach by covering
itself with the mucus of the stomach. Once covered, it is able to
fight any stomach acid that does reach it with urease, an enzyme it
possesses. Once nestled within the stomach mucus, H. pylori is able
to penetrate the protective lining of the stomach, induce
inflammatory cytokines, and cause gastric inflammation.
It is not currently known how H. pylori is transmitted or why some
people become symptomatic while others do not. The bacteria are
most likely spread from person to person through fecal-oral or
oral-oral routes. Contaminated water or food sources may also
contribute to the transmission of the bacteria.
The avoidance of H. pylori infection in infants and children is
particularly important, as the incidence of H. pylori infection is
greatest in childhood, particularly in developing countries where
infection rates can be as high as 50% by age 5 years. Precise
estimates of the age of acquisition of the invention are difficult
to obtain because most children that are infected are asymptomatic.
Even without symptoms, however, the infection can develop into more
dangerous conditions such as antral gastritis, the most common
manifestation in children. In addition, if an individual becomes
infected with H. pylori during childhood, the infection may remain
in his system throughout the course of his life, potentially
leading to other diseases in adulthood.
Treatment for H. pylori infection currently consists of 10 days to
2 weeks of antibiotic treatment, such as with amoxicillin,
tetracycline, metronidazole, or clarithromycin, plus either
ranitidine bismuth citrate, bismuth subsalicylate, or a proton pump
inhibitor. The disadvantage to widespread antibiotic treatment is
the development of antibiotic resistance. The H. pylori infection
has previously been shown to be resistant to several antibiotic
treatments, contributing to treatment failure in a number of cases.
F Megraud, H pylori Antibiotic Resistance: Prevalence, Importance,
and Advances in Testing, Gut 53: 1374-1384 (2004). In a particular
study, 29% of the H. pylori strains tested were resistant to
clarithromycin, 24% to metronidazole, and 10% were resistant to
both clarithromycin and metronidazole. Kato, et al., Antibiotic
Resistance of Helicobacter pylori Strains in Japanese Children, J.
Clin. Microbio. 40(2): 649-653 (2002). Thus, infected individuals
cannot be assured that antibiotic treatment will be effective.
Therefore, a need remains for a method for preventing or treating
H. pylori infection in subjects. It would also be beneficial to
provide a method for achieving such prevention or treatment through
the use of compositions other than traditional antibiotics.
SUMMARY OF THE INVENTION
Briefly, therefore, the present invention is directed to a
nutritional composition comprising astaxanthin, beta-carotene,
galacto-oligosaccharide, and polydextrose.
In another embodiment, the invention is directed to a method for
inhibiting the growth of pathogenic bacteria in a subject
comprising administering to the subject an effective amount of
astaxanthin and beta-carotene.
The invention is additionally directed to a method for inhibiting
the growth of H. pylori in an infant comprising administering to
the infant an infant formula containing an effective amount of
astaxanthin and beta-carotene.
In other embodiments, the invention is directed to a method for
preventing or treating a bacterial infection or preventing obesity
in a subject comprising administering to the subject a nutritional
composition comprising astaxanthin, beta-carotene,
galacto-oligosaccharide, and polydextrose.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Reference now will be made in detail to the embodiments of the
invention, one or more examples of which are set forth below. Each
example is provided by way of explanation of the invention, not a
limitation of the invention. In fact, it will be apparent to those
skilled in the art that various modifications and variations can be
made in the present invention without departing from the scope or
spirit of the invention. For instance, features illustrated or
described as part of one embodiment, can be used on another
embodiment to yield a still further embodiment.
Thus, it is intended that the present invention covers such
modifications and variations as come within the scope of the
appended claims and their equivalents. Other objects, features and
aspects of the present invention are disclosed in or are obvious
from the following detailed description. It is to be understood by
one of ordinary skill in the art that the present discussion is a
description of exemplary embodiments only, and is not intended as
limiting the broader aspects of the present invention.
Carotenoids are a related group of greater than 600 natural
compounds, irrespective of geometric and stereoisomers, with
demonstrated antioxidant efficacy. The carotenoids are broadly
divided into "carotenes," or non-oxygen substituted hydrocarbon
carotenoids, and "xanthophylls," oxygen-substituted carotenoids.
Between 500 and 600 carotenoids have been identified, of which only
about 24 occur in human foodstuffs. The major carotenoids found in
foods are .alpha.-carotene, .beta.-carotene, lycopene, lutein,
zeaxanthin, and .beta.-cryptoxanthin. They are present in foods
such as carrots, pumpkins, sweet potatoes, tomatoes, and other deep
green, yellow, orange, red fruits and vegetables. Most carotenoids
occur in nature predominantly in the all-trans form. Three of these
carotenoids, .alpha.-carotene, .beta.-carotene and
.beta.-cryptoxanthin, can be converted into retinol and are
therefore considered provitamin A carotenoids. Lycopene, lutein and
zeaxanthin do not have a vitamin A function and are referred to as
nonprovitamin A carotenoids.
An important feature of carotenoids is a centrally located,
extended conjugated double-bond system, which is responsible for
the chemical reactivity, light-absorbing properties, and, thus, the
color of carotenoids. Potential biological function is determined
by the chemical structure of carotenoids. The alternating single
and double bond of the polyene backbone of carotenoids allow them
to absorb excess energy from other molecules, which accounts for
their antioxidant properties. They perform their antioxidant
function by either quenching singlet oxygen and/or blocking free
radical-mediated reactions. The polarity of the specific end groups
of carotenoids accounts for the differences in how they interact
with biological membranes. Carotenoids are associated with lipid
portions of human tissues, cells, and membranes and bind to
hydrophobic surfaces because they are lipophilic. In addition,
carotenoids are easily isomerized and oxidized due to their high
unsaturation and hence may lose biological activity after
processing and storage.
In recent years, carotenoids have received the interest of
researchers from diverse fields including food science, pharmacy,
biochemistry and nutrition because of their wide spectrum of
biological functions such as provitamin A, antioxidant,
immuno-enhancement, and prevention of degenerative diseases.
For example, see U.S. Pat. No. 7,090,879 to Albrecht, et al., U.S.
Pat. No. 6,268,450 to Asami, et al., U.S. Pat. No. 6,727,373 to
Bijl, et al., U.S. Patent App. Pub. No. 2003/0175364 to Newman, et
al., or U.S. Patent App. Pub. No. 2006/0068019 to Dalziel, et
al.
The technical problem to be solved by the present invention is to
provide novel carotenoid nutritional compositions that are useful
in inhibiting the growth of pathogenic bacteria and/or preventing
or treating bacterial infections in subjects. Thus, in an
embodiment, the present invention is directed to a nutritional
composition comprising astaxanthin, beta-carotene,
galacto-oligosaccharide, and polydextrose. The present invention is
also directed, in an embodiment, to a method for inhibiting the
growth of pathogenic bacteria or for preventing or treating
bacterial infections in subjects by administering to them an
effective amount of astaxanthin and beta-carotene.
Astaxanthin is a fat-soluble, oxygenated pigment which is
classified as a xanthophyll and is a member of the carotenoid
family. It has a unique molecular structure that gives it powerful
antioxidant function. It can be extracted from salmon, microalgae,
and Pfaffia, a yeast. Current research shows that due to
astaxanthin's potent antioxidant activity, it may be beneficial in
cardiovascular, immune, anti-inflammatory, and neurodegenerative
diseases. Specifically, its varied actions include: inhibition of
lipid peroxidation at the cell level; crossing the blood-brain
barrier, effecting treatment of ocular and neurodegenerative
diseases such as glaucoma and Alzheimer's; entrapment of free
radicals by adding them to its long, double-bonded chain rather
than donating an electron; stabilization of the cell membrane via
its polar end groups spanning the cell membrane and increasing its
rigidity and mechanical strength; neutralization of singlet and
triplet oxygen (de-charges) generated by UVA and UVB radiation and
other sources; binding to a lipoprotein, an efficient transport
vehicle, making it more bioavailable; increase of immune system
function including heightened production of antibody-secreting
cells and Interleukin 2 and suppression of interferon-gamma;
inhibition of reactive oxygen species that cause inflammation;
enhancing of the antioxidant actions of Vitamin E and Vitamin C;
and encouraging the release of Vitamin A from the liver when
needed.
Astaxanthin provides significantly more antioxidant capacity than
other carotenoids and antioxidants such as beta-carotene and
Vitamin E. In fact, Astaxanthin has 100-500 times the antioxidant
capacity of Vitamin E and 10 times the antioxidant capacity of
beta-carotene. Many laboratory studies also indicate astaxanthin is
a stronger antioxidant than lutein, lycopene and tocotrienols.
Astaxanthin is often added to food products or nutritional
supplements for its antioxidant effects.
The structure of astaxanthin is shown below:
##STR00001##
In an embodiment of the invention, the effective amount of
astaxanthin is within the range of about 0.01 mg and about 10 mg
per kg body weight per day. In another embodiment of the invention,
the effective amount of astaxanthin is within the range of about
0.1 mg and about 5 mg per kg body weight per day. In a particular
embodiment of the invention, the effective amount of astaxanthin is
about 1 mg per kg body weight per day.
Like astaxanthin, beta-carotene is a carotenoid. Beta-carotene is
the most common of the carotenes and can be found in yellow,
orange, and green leafy fruits and vegetables. It is unclear
whether beta-carotene has any biological function for humans other
than as a precursor for vitamin A. There is some evidence that
beta-carotene may play a beneficial role in human nutrition beyond
its provitamin A function. Beta-carotene has antioxidant activity,
at least in vitro, and it may enhance intercellular communication
and may have immunomodulatory and anticarcinogenic activities in
certain circumstances.
The structure of beta-carotene is set forth below:
##STR00002##
In an embodiment of the invention, the effective amount of
beta-carotene is within the range of about 0.01 mg and about 10 mg
per kg body weight per day. In another embodiment of the invention,
the effective amount of beta-carotene is within the range of about
0.1 mg and about 5 mg per kg body weight per day. In a particular
embodiment of the invention, the effective amount of beta-carotene
is about 1 mg per kg body weight per day.
As used in the present invention, the source of either astaxanthin
or beta-carotene can be any source known in the art such as plant
material, seafood, and/or single cell. In certain embodiments,
either of astaxanthin or beta-carotene may be in raw form or may be
chemically manipulated. In a particular embodiment, either of
astaxanthin or beta-carotene may be genetically modified
organisms.
As noted, the present invention is directed, in certain
embodiments, methods for inhibiting the growth of pathogenic
bacteria or for preventing or treating bacterial infections in
subjects by administering to them an effective amount of
astaxanthin and beta-carotene. The pathogenic bacteria which
experience growth inhibition as a result of the invention may be
any pathogenic bacteria known in the art. In a particular
embodiment, the pathogenic bacteria is H. pylori. Likewise, the
bacterial infection of the invention may be any known in the art,
but in a particular embodiment, is H. pylori infection.
In an embodiment, the astaxanthin and beta carotene may be
administered in the form of a nutritional composition, infant
formula, human milk supplement, or children's nutritional product.
As used herein, the term "infant formula" means a composition that
satisfies the nutrient requirements of an infant by being a
substitute for human milk. Thus, the method of the invention is
useful in preventing or treating bacterial infections in human
infants, children, or adults.
If the astaxanthin and beta-carotene are administered via an infant
formula, the infant formula may be nutritionally complete and
contain suitable types and amounts of lipid, carbohydrate, protein,
vitamins and minerals. The amount of lipid or fat typically can
vary from about 3 to about 7 g/100 kcal. The amount of protein
typically can vary from about 1 to about 5 g/100 kcal. The amount
of carbohydrate typically can vary from about 8 to about 12 g/100
kcal. Protein sources can be any used in the art, e.g., nonfat
milk, whey protein, casein, soy protein, hydrolyzed protein, and/or
amino acids. Carbohydrate sources can be any used in the art, e.g.,
lactose, glucose, corn syrup solids, maltodextrins, sucrose,
starch, and/or rice syrup solids. Lipid sources can be any used in
the art, e.g., vegetable oils such as palm oil, canola oil, corn
oil, soybean oil, palmolein, coconut oil, medium chain triglyceride
oil, high oleic sunflower oil, and/or high oleic safflower oil.
Conveniently, commercially available nutritional compositions,
infant formulas, human milk supplements, or children's nutritional
products can be used. For example, Enfalac, Enfamil.RTM.,
Enfamil.RTM. Premature Formula, Enfamil.RTM. with Iron,
Enfamil.RTM. LIPIL.RTM., Lactofree.RTM., Nutramigen.RTM.,
Pregestimil.RTM., and ProSobee.RTM. (available from Mead Johnson
& Company, Evansville, Ind., U.S.A.) may be supplemented with
suitable levels of astaxanthin and beta-carotene and used in
practice of the invention.
If the astaxanthin and beta-carotene are administered in an infant
formula, the amounts of each carotenoid in the formula may be up to
about 40 nmol/g fat. In another embodiment, the amounts of each
carotenoid in the formula may be within the range of about 2 nmol/g
and about 35 nmol/g fat. In a particular embodiment, the amounts of
each carotenoid in the formula may be within the range of about 5
nmol/g and about 30 nmol/g fat.
The total carotenoid blend may comprise, in an embodiment, up to
about 2000 mcg/L infant formula. In other embodiments, the total
carotenoid blend may comprise from about 100 to about 1500 mcg/L
infant formula. In yet another embodiment, the total carotenoid
blend may comprise from about 200 to about 1200 mcg/L infant
formula.
The individual carotenoids may be present in the infant formula in
an amount of from about 50 to about 1150 mcg/L, about 75 to about
230 mcg/L, or about 100 to about 200 mcg/L.
In some embodiments of the invention, additional components may be
administered in combination with astaxanthin and beta-carotene.
These additional components may include probiotics, prebiotics, or
long chain polyunsaturated fatty acids (LCPUFAs). The components
may be administered separately from the astaxanthin and
beta-carotene or may be included as part of a nutritional
composition, infant formula, human milk supplement, or children's
nutritional product that contains astaxanthin, beta-carotene, and
one or more additional components.
The term "probiotic" means a microorganism that exerts beneficial
effects on the health of the host. Any probiotic known in the art
may be used, provided it is suitable for combination with the other
components of the supplement. For example, the probiotic may be
chosen from the group consisting of Lactobacillus and
Bifidobacterium. Alternatively, the probiotic can be Lactobacillus
rhamnosus GG.
The term "prebiotic", as used herein, means a non-digestible food
ingredient that stimulates the growth and/or activity of
probiotics. In this embodiment, any prebiotic known in the art may
be used, provided it is suitable for combination with the other
components of the supplement. In a particular embodiment, the
prebiotic can be selected from the group consisting of
fructo-oligosaccharide, gluco-oligosaccharide,
galacto-oligosaccharide, inulin, isomalto-oligosaccharide,
polydextrose, xylo-oligosaccharide, lactulose, and combinations
thereof. In a particular embodiment, the prebiobic is a mixture of
galacto-oligosaccharide and polydextrose.
In an embodiment, the total amount of prebiotics present in the
nutritional composition may be from about 1.0 g/L to about 10.0 g/L
of the composition. In another embodiment, the total amount of
prebiotics present in the nutritional composition may be from about
2.0 g/L and about 8.0 g/L of the composition. In yet another
embodiment, the total amount of prebiotics present in the
nutritional composition may be about 4.0 g/L of the
composition.
If galacto-oligosaccharide is used as a prebiotic, the amount of
galacto-oligosaccharide in the nutritional composition may, in an
embodiment, be within the range of from about 1.0 g/L to about 4.0
g/L. In another embodiment, the amount of galacto-oligosaccharide
in the nutritional composition may be about 2.0 g/L. If
polydextrose is used as a prebiotic, the amount of polydextrose in
the nutritional composition may, in an embodiment, be within the
range of from about 1.0 g/L to about 4.0 g/L. In another
embodiment, the amount of polydextrose in the nutritional
composition may be about 2.0 g/L. In a particular embodiment,
galacto-oligosaccharide and polydextrose are supplemented into the
nutritional composition in a total amount of about 4.0 g/L. In this
embodiment, the amount of galacto-oligosaccharide may be about 2.0
g/L and the amount of polydextrose may be about 2.0 g/L.
While not wishing to be bound to this or any theory, it is believed
that the administration of prebiotics and carotenoids may provide a
synergistic effect. More specifically, it is believed that the
prebiotic may alter the composition of the gut flora to provide a
greater number of beneficial bacteria and fewer pathogenic
bacteria, further contributing to the antimicrobial effect of the
carotenoids in the present invention.
In yet another embodiment of the invention, LCPUFAs may be
administered in combination with astaxanthin and beta-carotene. In
this embodiment, the LCPUFAs may include docosahexaenoic acid
(DHA), arachidonic acid (ARA), and/or eicosapentaenoic acid
(EPA).
If administered as part of the present invention, the weight ratio
of ARA:DHA may be from about 1:3 to about 9:1. In one embodiment of
the present invention, this ratio is from about 1:2 to about 4:1.
In yet another embodiment, the ratio is from about 2:3 to about
2:1. In one particular embodiment the ratio is about 2:1. In
another particular embodiment of the invention, the ratio is about
1:1.5. In other embodiments, the ratio is about 1:1.3. In still
other embodiments, the ratio is about 1:1.9. In a particular
embodiment, the ratio is about 1.5:1. In a further embodiment, the
ratio is about 1.47:1.
If administered as part of the present invention, the level of DHA
may be within the range of about 0.0% and about 1.00% of fatty
acids, by weight. In other embodiments, the level of DHA may be
about 0.32% by weight. In some embodiments, the level of DHA may be
about 0.33% by weight. In another embodiment, the level of DHA may
be about 0.64% by weight. In another embodiment, the level of DHA
may be about 0.67% by weight. In yet another embodiment, the level
of DHA may be about 0.96% by weight. In a further embodiment, the
level of DHA may be about 1.00% by weight.
If administered as part of the present invention, the level of ARA
may be within the range of 0.0% and 0.67% of fatty acids, by
weight. In another embodiment, the level of ARA may be about 0.67%
by weight. In another embodiment, the level of ARA may be about
0.5% by weight. In yet another embodiment, the level of DHA may be
within the range of about 0.47% and about 0.48% by weight.
If administered as part of the present invention, the amount of DHA
may be from about 2 mg/100 kilocalories (kcal) to about 100 mg/100
kcal. In another embodiment, the amount of DHA may be from about 5
mg/100 kcal to about 75 mg/100 kcal. In yet another embodiment, the
amount of DHA may be from about 15 mg/100 kcal to about 60 mg/100
kcal.
If administered as part of the present invention, the amount of ARA
may be from about 4 mg/100 kilocalories (kcal) to about 100 mg/100
kcal. In another embodiment, the amount of ARA may be from about 10
mg/100 kcal to about 67 mg/100 kcal. In yet another embodiment, the
amount of ARA may be from about 20 mg/100 kcal to about 50 mg/100
kcal. In a particular embodiment, the amount of ARA may be from
about 25 mg/100 kcal to about 40 mg/100 kcal. In one embodiment,
the amount of ARA is about 30 mg/100 kcal.
If administered as part of the present invention, the effective
amount of DHA may be from about 3 mg per kg of body weight per day
to about 150 mg per kg of body weight per day. In one embodiment of
the invention, the amount is from about 6 mg per kg of body weight
per day to about 100 mg per kg of body weight per day. In another
embodiment the amount is from about 15 mg per kg of body weight per
day to about 60 mg per kg of body weight per day.
If administered as part of the present invention, the effective
amount of ARA may be from about 5 mg per kg of body weight per day
to about 150 mg per kg of body weight per day. In one embodiment of
this invention, the amount varies from about 10 mg per kg of body
weight per day to about 120 mg per kg of body weight per day. In
another embodiment, the amount varies from about 15 mg per kg of
body weight per day to about 90 mg per kg of body weight per day.
In yet another embodiment, the amount varies from about 20 mg per
kg of body weight per day to about 60 mg per kg of body weight per
day.
If the composition of the invention is supplemented with oils
containing LCPUFAs, it may be accomplished using standard
techniques known in the art. For example, an equivalent amount of
an oil which is normally present in a composition, such as high
oleic sunflower oil, may be replaced with the LCPUFAs.
If utilized, the source of the LCPUFAs can be any source known in
the art such as marine oil, fish oil, single cell oil, egg yolk
lipid, and/or brain lipid. The LCPUFAs can be in natural form or
refined form.
In other embodiments of the invention, astaxanthin and
beta-carotene may be combined and administered to a subject for the
purpose of treating or preventing any of the following: reflux,
spitting up, abdominal pain, bloating, vomiting, gastric
inflammation, gastritis, ulcer formation, hypertension,
dyslipidemia, Type I and II diabetes, insulin sensitivity, obesity,
cardiovascular disease, cancer, atherosclerosis. In other
embodiments, astaxanthin and beta-carotene can be combined and
administered for the purpose of improving digestion or stool
consistency, modulating antioxidant enzymes, decreasing cellular
and tissue oxidative stress, shifting T-helper cell Types 1 to Th2
balance, and modulating immune function.
In some embodiments, the invention includes a method for improving
weight management in a subject comprising administering to the
subject an effective amount of astaxanthin and beta-carotene. In
other embodiments, the invention includes a method for preventing
or treating obesity in a subject comprising administering to the
subject an effective amount of astaxanthin and beta-carotene.
Obesity has been linked with an inflammation of adipose tissue. In
some studies, inflammation has also been identified as an early
characteristic of obesity. The combination of astaxanthin and
beta-carotene, in addition to their antioxidant benefits, may
contribute to a reduction in inflammation, thereby reducing or
preventing the onset of obesity in the present invention.
In an embodiment, the invention is directed to the use of a
combination of astaxanthin and beta-carotene in the manufacture of
an ingestible composition for inhibiting the growth of pathogenic
bacterial in a subject. In another embodiment, the invention is
directed to the use of a combination of astaxanthin and
beta-carotene in the manufacture of an ingestible composition for
inhibiting the growth of H. pylori in an infant. In yet another
embodiment, the invention is directed to the use of a combination
of astaxanthin and beta-carotene in the manufacture of an
ingestible composition for preventing or treating a bacterial
infection in a subject. In still another embodiment, the invention
is directed to the use of a combination of astaxanthin and
beta-carotene in the manufacture of an ingestible composition for
preventing obesity in a subject.
The invention, in an embodiment, is also directed to a combination
of astaxanthin and beta-carotene for use in inhibiting the growth
of pathogenic bacteria in a subject. The invention is also
directed, in an embodiment, to a combination of astaxanthin and
beta-carotene for use in inhibiting the growth of H. pylori in an
infant. Additionally, the invention is directed, in an embodiment,
to a combination of astaxanthin and beta-carotene for use in
preventing or treating a bacterial infection in a subject.
All references cited in this specification, including without
limitation, all papers, publications, patents, patent applications,
presentations, texts, reports, manuscripts, brochures, books,
internet postings, journal articles, and/or periodicals are hereby
incorporated by reference into this specification in their
entireties. The discussion of the references herein is intended
merely to summarize the assertions made by their authors and no
admission is made that any reference constitutes prior art.
Applicants reserve the right to challenge the accuracy and
pertinence of the cited references.
These and other modifications and variations to the present
invention may be practiced by those of ordinary skill in the art,
without departing from the spirit and scope of the present
invention, which is more particularly set forth in the appended
claims. In addition, it should be understood that aspects of the
various embodiments may be interchanged in whole or in part.
Furthermore, those of ordinary skill in the art will appreciate
that the foregoing description is by way of example only, and is
not intended to limit the invention so further described in such
appended claims. Therefore, the spirit and scope of the appended
claims should not be limited to the description of the preferred
versions contained therein.
* * * * *
References